A New Supplement for the Immune Response to HPV Infection

University of Messina60 enrolled

Overview

The purpose of this study is to evaluate whether a supplement in which ellagic acid plus annona muricata are combined, may modulate the immune response to high risk HPV infection. Sixty women will be enrolled in a randomized, controlled study, having a histological diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the activation of onco suppressor protein by the supplement and secondary outcome is the clearance of HPV infection in the treated group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HPV Infection

Interventions

ellagic acid + annona muricataDRUG

pills

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * women with high risk HPV infection * histological diagnosis of L-SIL Exclusion Criteria: * women with no high risk HPV infection * women without histological diagnosis of L-SIL

Outcomes

Primary Outcomes

variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells

Time frame: 6 months

Secondary Outcomes

clearance of the HPV infection

Time frame: 6 months

Data from ClinicalTrials.gov

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